Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

• Status: Terminated
• Trial end date: 2021-05-04
• Target enrollment: 0
• Participant gender: All

Summary

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Linagliptin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.

3. Confirmation of infection with SARS-CoV-2 by PCR testing.

4. Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).

Exclusion Criteria:

1. WHO COVID-19 Ordinal Scale for Clinical Improvement ≥ 6.

2. Respiratory failure requiring mechanical ventilation prior to randomization.

3. Use of vasopressor or inotropic medications prior to randomization.

4. Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.

5. Patients expected to require intensive care unit admission or immediate surgical intervention.

6. Participation in another trial assessing any treatment for COVID-19.

7. Current treatment with a DPP-4 inhibitor.

8. Pregnancy.